Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP)

Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP): a Prospective, Randomized Controlled Trial

Sponsors

Lead Sponsor: Shandong University

Source Shandong University
Brief Summary

The project was organized by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of different cycles of high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

Detailed Description

The investigators are undertaking a multicenter, randomized, controlled trial of 200 primary ITP adult patients from 11 medical centers in China. One part of the participants are randomly selected to receive four cycles of high-dose dexamethasone (given orally at a dose of 40mg per day for 4 consecutive days every 14 days for 4 cycles), comparing the others with one cycle (given orally at a dose of 40 mg per day for 4 consecutive days).

Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of different cycles of high-dose dexamethasone therapy for the treatment of adults with ITP.

Overall Status Withdrawn
Start Date November 2015
Completion Date November 2018
Primary Completion Date November 2018
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
sustained response to treatment 6 months after treatment started
Secondary Outcome
Measure Time Frame
Evaluation of early response 2 months after treatment started
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dexamethasone (4 cycles)

Description: dexamethasone 40mg daily for 4 consecutive days every 14 days for 4 courses

Arm Group Label: 4 cycles

Other Name: DXM 4

Intervention Type: Drug

Intervention Name: Dexamethasone (1 cycle)

Description: dexamethasone 40mg daily for 4 consecutive days

Arm Group Label: 1 cycle

Other Name: DXM 1

Eligibility

Criteria:

Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia.

2. Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80 years.

3. To show a platelet count <30 * 10^9/L, and with bleeding manifestations.

4. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.

2. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.

3. Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.

4. Current HIV infection or hepatitis B virus or hepatitis C virus infections.

5. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)

6. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.

7. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.

8. Patients who are deemed unsuitable for the study by the investigator.

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Ming Hou, MD, PhD Principal Investigator Shandong University, Qilu Hospital
Location
Facility: Qilu Hospital, Shandong University
Location Countries

China

Verification Date

December 2015

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Shandong University

Investigator Full Name: Ming Hou

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 4 cycles

Type: Experimental

Description: Oral administration of dexamethasone 40 mg for four consecutive days every 14 days for 4 courses

Label: 1 cycle

Type: Active Comparator

Description: Oral administration of dexamethasone 40 mg for four consecutive days

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov